Noxopharm Ltd (ASX:NOX)’s CEO Dr Gisela Mautner discusses the hard work that went into procuring an orphan drug designation for its leading sarcoma treatment, Veyonda® with Proactive. The designation secures Noxopharm’s place at the forefront of this treatment application by giving Veyonda® seven years of market exclusivity.
Almost as important is the attached waiver of new drug application fees, which could save Noxopharm US$3 million, and opportunities for grant funding from the Office of Orphan Products Development. Finally, the Orphan Drug Designation allows the company to leverage regulatory assistance from the Federal Drug Administration (FDA) in future applications.